Dr John Sweetenham Outlines the Effect of Current Policies on the Implementation of CAR T Therapy

There are a number of policy changes that can drive change within the implementation of chimeric antigen receptor (CAR) T-cell therapy, but further innovation is warranted to improve access, said John Sweetenham, MD, professor in the Department of Internal Medicine at UT Southwestern Medical Center and the Associate Director for Clinical Affairs at UTSW’s Harold C. Simmons Comprehensive Cancer Center.

Transcript

What policies have helped or hindered the implementation of CAR T-cell therapy?

So, I think just recently, there are a number of policy changes, for which overall, I think going to prove to be helpful. Probably not helpful enough, but I think they certainly caused some improvements. The first one of those is that CMS has recognized that it will fund up to a certain extent CAR T-cell therapy for the license indications, which at the moment are predominantly in B-cell malignancy, but it also has recognized that it is essential to cover the cost of CAR T for any other indications, which are listed in authoritative compendia of which the National Comprehensive Cancer Network, 1, is probably the most respected and best referenced. So, I think those are positive things. The other positive outcome of the recent change in the national coverage determination is that the amount of reimbursement is increased from 50% of cost to 65% of cost.

So, those things are all good and I think they help us provide this treatment to more of our patients. The problem and the hindrance is that it really still falls a very long way short of the true cost of the treatment. The cells themselves cost somewhere between $370,000 to $450,000, and at the moment with the current reimbursement models, the best that we can do if patients are treated as inpatients is to recover about 80% of that by the time we factor in the new technology, add-on payments as well. So, for most big centers, who are performing inpatient CAR T-cell treatments at the moment, they stand to lose at a minimum probably about $100,000 per patient and that is purely on the price of the CAR T cells. So, that doesn't really factor in what will happen if the patient gets toxicity, needs to be admitted to the [intensive care unit], and so on.

So, I think that what I would say is that the recent policy changes have been definitely a step in the right direction. I think that we still have quite a long way to go, but it undoubtedly will slowly improve the access. The other thing that needs to happen on our end is as oncologists, we need to strengthen the evidence base because I think that's the other thing that's lacking. Then perhaps the final thing I'd say, and I'm definitely in a minority with this opinion, but at some level when Medicare—when CMS decided to increase the new technology add-on payments, under the new policy change for coverage, it was anticipated that there would be a provision in there that it will be coverage with evidence development so that we would be required to prospectively collect evidence for the efficacy. That requirement was dropped, and I think the reasons for that were good because the feeling is that will accelerate access. On the other hand, I think the downside of that is that it was an opportunity for us to get more of the evidence base that we really need.